Squirt Fluid Delivery System
FDA 510(k) K981417 · Merit Medical Systems, Inc.
510(k) numberK981417
Submission
- Device name
- Squirt Fluid Delivery System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- April 20, 1998
- Decision date
- July 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEY – Mechanical Thrombolysis Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
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Questions and answers
When was Squirt Fluid Delivery System cleared by the FDA?
Squirt Fluid Delivery System (K981417) received a 510(k) decision of Substantially Equivalent on July 17, 1998, 88 days after the submission was received.
What is the product code of K981417?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.